VAERS Reports UJ530AAA

VAERS 1478280

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ530AAA

mild

Staat: VA
Alter: 0,3
Geschlecht: F
Eingang: 16.07.2021
Impfdatum: 16.07.2021
Beginn: 16.07.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein

Erythema Pruritus Urticaria

Symptomtext

The baby broke out into hives. Redness and itchiness.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pruritus
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: DTAP+IPV+HIB: Redness of thigh

VAERS 2404195

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ530AAA

gering

Staat: VA
Alter: 4,0
Geschlecht: F
Eingang: 08.08.2022
Impfdatum: 26.07.2022
Beginn: 26.07.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

have administered an expired Pentacel with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who was administered an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 26-Jul-2022, the patient received a 3rd dose (0.5ml, Once) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine (lot UJ530AAA, expiry date: 10-Jul-2022; strength: Standard, formulation: unknown) via intramuscular route in the right thigh for immunization. On 26-Jul-2022, (latency: same day) the patient was administered an expired pentacel with no reported adverse event (expired product administered). First time product used: No Still using product: No Action taken: Not applicable. Outcome: Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2397757

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ530AAA

gering

Staat: OH
Alter: 0,2
Geschlecht: F
Eingang: 01.08.2022
Impfdatum: 15.07.2022
Beginn: 15.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

they have administered expired pentacel to a patient with no reported adverse event; Initial information received on 21-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves 2 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE all for Prophylactic vaccination. On 15-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ530AAA, expiry date: 10-Jul-2022, Vial UJ530AA Expiration: 10-Jul-2022 Diluent U6985AA Expiration: 10-Jul-2022) via intramuscular route in the left deltoid for immunization (expired product administered, latency: same day). No adverse event reported. Action taken: Not applicable. Outcome: Unknown for the event they have administered expired pentacel to a patient with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -